Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy
Primary Purpose
Chronical Rotator Cuff Tendinopathy
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Eccentric training program
Traditional training program
Sponsored by
About this trial
This is an interventional treatment trial for Chronical Rotator Cuff Tendinopathy
Eligibility Criteria
Inclusion Criteria:
- global tendon thinning
- inhomogeneous echo partitioning
- calcifications at the insertion
- symptoms present for at least 3 months: painful resisted isometric abduction, painful palpation of the supraspinatus tendon, impingement tests positive
Exclusion Criteria:
- documented full thickness rotator cuff rupture
- other lesions than CRCT at the moment of the study
- echographic criteria for ruptures (focal thinning, fluid-filled gap,compressibility)
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Eccentric training program
Traditional training program
Outcomes
Primary Outcome Measures
Maximum force, pain and function,range of motion, force reproduction, subacromial space
Secondary Outcome Measures
Full Information
NCT ID
NCT00782522
First Posted
October 29, 2008
Last Updated
March 26, 2012
Sponsor
University Ghent
Collaborators
Special Research Fund, Belgium
1. Study Identification
Unique Protocol Identification Number
NCT00782522
Brief Title
Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy
Official Title
Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Special Research Fund, Belgium
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the first part of the the study two new outcome measurements (force reproducibility and subacromial space) will be tested for reproducibility. Therefore 30 healthy people will be assessed.
In a second part of the study 60 patients will be randomly allocated to two groups. Group A (n=30) will perform a traditional training program and group B (n=30) will perform an eccentric training program.
Before the onset of the training programs, pain, function, maximal force, range of motion, subacromial space and force reproducibility will be assessed. Both training programs will be accomplished at home. The first six weeks there will be an appointment with the therapist once a week to explain, correct and when necessary, aggravate the exercises. The next six weeks these appointments will be diminished to once every two weeks.
After 6 and after 12 weeks of training the patients will be reassessed for all the parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronical Rotator Cuff Tendinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Eccentric training program
Arm Title
2
Arm Type
Active Comparator
Arm Description
Traditional training program
Intervention Type
Procedure
Intervention Name(s)
Eccentric training program
Intervention Description
Eccentric training program
Intervention Type
Procedure
Intervention Name(s)
Traditional training program
Intervention Description
Traditional training program
Primary Outcome Measure Information:
Title
Maximum force, pain and function,range of motion, force reproduction, subacromial space
Time Frame
After 6 and after 12 weeks of training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
global tendon thinning
inhomogeneous echo partitioning
calcifications at the insertion
symptoms present for at least 3 months: painful resisted isometric abduction, painful palpation of the supraspinatus tendon, impingement tests positive
Exclusion Criteria:
documented full thickness rotator cuff rupture
other lesions than CRCT at the moment of the study
echographic criteria for ruptures (focal thinning, fluid-filled gap,compressibility)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Cools, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Effect Study of an Eccentric Training Program and Stretching for Patients With Chronical Rotator Cuff Tendinopathy
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